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Sistimi ea Tsamaiso ea LN₂ ea Haier Biomedical e Fumana Setifikeiti sa FDA

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Haufinyane tjena, TÜV SÜD China Group (eo ka mor'a moo e bitsoang "TÜV SÜD") e netefalitse lirekoto tsa elektroniki le li-signature tsa elektroniki tsa sistimi ea tsamaiso ea naetrojene ea metsi ea Haier Biomedical ho latela litlhoko tsa FDA 21 CFR Karolo ea 11. Litharollo tsa lihlahisoa tse leshome le metso e ts'eletseng, tse ntlafalitsoeng ke Haier Biomedical, ba fuoe tlaleho ea tumellano ea TÜV SÜD, ho kenyeletsoa letoto la Smartand Biobank.

Ho fumana setifikeiti sa FDA 21 CFR Karolo ea 11 ho bolela hore lirekoto tsa elektroniki le mesaeno ea sistimi ea taolo ea LN₂ ea Haier Biomedical e fihlella maemo a ts'epo, botšepehi, lekunutu le ts'ebetso, ka ho etsa joalo e netefatsa boleng ba data le ts'ireletso.Sena se tla potlakisa ho amoheloa ha litharollo tsa mokhoa oa ho boloka naetrojene ea metsi limmarakeng tse kang US le Europe, ho tšehetsa katoloso ea machaba ea Haier Biomedical.

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Ho fumana setifikeiti sa FDA, sistimi ea taolo ea naetrojene ea metsi ea HB e kene leetong le lecha la ho ikopanya ha lichaba tsa machaba.

TÜV SÜD, moetapele oa lefats'e oa tlhahlobo le setifikeiti tsa mokha oa boraro, o lula a tsepamisitse maikutlo ho faneng ka ts'ehetso ea boits'oaro ho liindasteri ho thusa likhoebo ho lula li latela melaoana e ntseng e fetoha.Tekanyetso ea FDA 21 CFR Karolo ea 11 e fanoeng ke Tsamaiso ea Lijo le Lithethefatsi ea U.S. (FDA), e fana ka lirekoto tsa elektroniki ka litlamorao tse tšoanang le tsa lirekoto tse ngotsoeng le mesaeno, e netefatsa bonnete le ts'epahalo ea data ea elektroniki.Tekanyetso ena e sebetsa ho mekhatlo e sebelisang lirekoto le li-signature tsa elektroniki ho biopharmaceuticals, lisebelisoa tsa bongaka le liindasteri tsa lijo.

Ho tloha ha e phatlalatsoa, ​​tekanyetso e se e amohetsoe lefatšeng ka bophara, eseng feela ke lik'hamphani tsa biopharmaceutical tsa Amerika, lipetlele, litsi tsa lipatlisiso le lilaboratori, empa hape ke Europe le Asia.Bakeng sa lik'hamphani tse itšetlehileng ka lirekoto tsa elektroniki le mesaeno, ho lumellana le litlhoko tsa FDA 21 CFR Karolo ea 11 ho bohlokoa bakeng sa katoloso e tsitsitseng ea machaba, ho netefatsa hore ho latela melao ea FDA le litekanyetso tse amehang tsa bophelo bo botle le polokeho.

Sistimi ea taolo ea naetrojene ea Haier Biomedical ea Haier Biomedical ha e le hantle ke "boko bo bohlale" bakeng sa lijana tsa naetrojene tse metsi.E fetola lisebelisoa tsa mohlala hore e be lisebelisoa tsa data, 'me lintlha tse ngata li behiloe leihlo, li rekotoa le ho bolokoa ka nako ea nnete, e lemosa ka mathata afe kapa afe.E boetse e na le litekanyo tse peli tse ikemetseng tsa mocheso le maemo a mokelikeli, hammoho le taolo ea maemo a ts'ebetso ea basebetsi.Ho feta moo, e fana ka taolo ea pono ea lisampole bakeng sa phihlello e potlakileng.Basebedisi ba ka fetola pakeng tsa mekhoa ea matsoho, ea khase, le ea mokelikeli ka ho tobetsa hanngoe, ho ntlafatsa ts'ebetso.Ntle le moo, sistimi e hokahana le sethala sa tlhahisoleseling sa IoT le BIMS, se nolofalletsang khokahano e se nang moeli har'a basebetsi, lisebelisoa le lisampole.Sena se fana ka boiphihlelo ba mahlale, bo tloaelehileng, bo bolokehileng, le bo sebetsang hantle haholo bo tlase ba mocheso.

Haier Biomedical e hlahisitse tharollo e felletseng ea polokelo ea naetrojene ea mokelikeli o le mong o loketseng lits'oants'o tsohle le likarolo tsa molumo, e shebane le litlhoko tse fapaneng tsa taolo ea polokelo ea sampole ea cryogenic.Tharollo e akaretsa maemo a fapaneng, ho kenyeletsoa bongaka, laboratori, polokelo ea mocheso o tlase, letoto la likokoana-hloko, le letoto la lipalangoang tsa baeloji, 'me e fa basebelisi boiphihlelo ba ts'ebetso e felletseng ho kenyelletsa moralo oa boenjiniere, polokelo ea sampole, ho khutlisa sampole, lipalangoang tsa mohlala, le tsamaiso ea sampole.

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Ka ho ikamahanya le litekanyetso tsa FDA 21 CFR Karolo ea 11, Haier Biomedical's CryoBio liquid nitrogen system system e netefalitsoe bakeng sa ho nepahala ha mesaeno ea rona ea elektroniki le botšepehi ba lirekoto tsa rona tsa elektroniki.Setifikeiti sena sa tumellano se ntlafalitse le ho feta tlholisano ea mantlha ea Haier Biomedical lebaleng la litharollo tsa polokelo ea naetrojene ea metsi, e potlakisang keketseho ea lets'oao limmarakeng tsa lefats'e.

Potlakisa phetoho ea machaba ho hohela basebelisi, le ho ntlafatsa tlholisano ea limmaraka tsa lefats'e

Haier Biomedical esale e latela leano la machabeng, e ntse e tsoela pele ho khothaletsa "network + localization" sistimi e habeli.Ka nako e ts'oanang, re ntse re tsoela pele ho matlafatsa nts'etsopele ea lits'ebetso tsa mebaraka ho tobana le basebelisi, ho ntlafatsa tharollo ea maemo a rona ho tšebelisano, ho itlhophisa, le ho fana.

E tsepamisitse maikutlo ho theheng phihlelo e ntle ka ho fetisisa ea mosebedisi, Haier Biomedical e matlafatsa sebaka sa libaka ka ho theha lihlopha tsa libaka le mekhoa ea ho arabela ka potlako litlhoko tsa basebelisi.Qetellong ea 2023, Haier Biomedical e na le marang-rang a kabo ea mose ho maoatle a balekane ba fetang 800, a sebelisana 'moho le bafani ba litšebeletso tse fetang 500 ka mor'a thekiso.Ho sa le joalo, re thehile tsamaiso ea setsi sa phihlelo le koetliso, e shebaneng le United Arab Emirates, Nigeria le United Kingdom, le tsamaiso ea setsi sa polokelo ea thepa le thepa e fumanehang Netherlands le United States.Re tebisitse tikoloho ea rona UK mme butle-butle ra etsa mohlala ona lefatšeng ka bophara, re matlafatsa tsamaiso ea rona ea mebaraka ea mose ho maoatle kamehla.

Haier Biomedical e boetse e potlakisa katoloso ea lihlahisoa tse ncha, ho kenyeletsoa lisebelisoa tsa laboratori, lisebelisoa, le li-pharmacy tse bohlale, e ntlafatsang tlholisano ea tharollo ea maemo a rona.Bakeng sa basebelisi ba mahlale a bophelo, li-centrifuges tsa rona li entse tsoelo-pele Europe le Amerika, li-dryer tsa rona li fumane liodara tsa pele Asia, 'me likhabinete tsa rona tsa biosafety li kene' marakeng oa Europe bochabela.Ho sa le joalo, lisebelisoa tsa rona tsa laboratori li fihletsoe le ho kopitsoa Asia, Amerika Leboea le Europe.Bakeng sa litsi tsa bongaka, ntle le litharollo tsa ente ea letsatsi, lihatsetsi tsa meriana, litsi tsa polokelo ea mali le lintho tse sebelisoang le tsona li ntse li hōla ka potlako.Ka tšebelisano e tsoelang pele le mekhatlo ea machaba, Haier Biomedical e fana ka lits'ebeletso tse kenyelletsang kaho ea laboratori, tlhahlobo ea tikoloho le ho thibela likokoana-hloko, ho theha menyetla e mecha ea kholo.

Qetellong ea 2023, mefuta e fetang 400 ea Haier Biomedical e se e netefalitsoe mose ho maoatle, 'me e atlehile ho isoa mererong e mengata e meholo Zimbabwe, Democratic Republic of Congo, Ethiopia, le Liberia, hammoho le China-Africa Union Centers of Disease Control. (CDC), e bonts'ang ntlafatso ea ts'ebetso ea phano.Lihlahisoa tsa rona le litharollo li amohetsoe haholo linaheng le libakeng tse fetang 150.Ka nako e ts'oanang, re bolokile tšebelisano ea nako e telele le mekhatlo ea machaba e fetang 60, ho kenyeletsoa Mokhatlo oa Lefatše oa Bophelo (WHO) le UNICEF.

Ho fumana setifikeiti sa FDA 21 CFR Karolo ea 11 ke mohato oa bohlokoa ho Haier Biomedical ha re ntse re shebana le boqapi leetong la rona la katoloso ea lefats'e.E boetse e bonts'a boitlamo ba rona ba ho fihlela litlhoko tsa basebelisi ka boqapi.Ha re shebile pele, Haier Biomedical e tla tsoelapele ka mokhoa oa rona oa boqapi ba mantlha ba basebelisi, e nts'etsapele phepelo ea maano a lefats'e ho pholletsa le libaka, liteishene le mekhahlelo ea lihlahisoa.Ka ho toboketsa boqapi ba lehae, re ikemiselitse ho hlahloba mebaraka ea machabeng ka bohlale.


Nako ea poso: Jul-15-2024